Komplian dan Pelesenan
Komplians dan Pelesenan
Berdasarkan Peraturan-peraturan Kawalan Dadah dan Kosmetik 1984, mana-mana syarikat yang ingin mengilang, mengimport dan memborong sebarang produk berdaftar perlu mempunyai Lesen Pengilang, Lesen Mengimport dan Lesen Pemborong. Pengisuan lesen-lesen tersebut dijalankan oleh Unit Pelesenan, Pusat Komplians dan Pelesenan (PKP).
- Garis Panduan
- Direktif & Pekeliling
- Laman Utama Industri
- Data Pemeriksaan
- Soalan-soalan Lazim : Pelesenan
- Soalan-soalan Lazim : Pemeriksaan APB
- Soalan-soalan Lazim : Amalan Pengedaran Baik (AEB)
Maklumat Terkini, Direktif dan Pekeliling
- Maklumat terkini berkenaan Garis Panduan, Direktif, Pekeliling, Soalan-soalan Lazim dan Pengumuman oleh Pusat Komplians dan Kawalan Kualiti (PKKK).
- Direktif dan Pekeliling berkaitan aktiviti pelesenan dan pemeriksaan.
1. Introduction
Cosmetic products in Malaysia are regulated under the Control of Drugs and Cosmetic Regulations (CDCR) 1984 which were promulgated under the Sale of Drugs Act 1952.
In agreement with the harmonisation of cosmetic through the ASEAN Cosmetic Directive (ACD), cosmetic products in Malaysia are controlled through notification procedure starting from 1stJanuary 2008. The CNH is required to COMPLY with all requirements stated in this guideline and to make a declaration upon notification to the Director of Pharmaceutical Services (known as DPS) through National Pharmaceutical Regulatory Agency (NPRA). Regulatory action will be taken in the event of false declaration and/or product found to be non- compliant to the stipulated regulations and guidelines.
Under the CDCR 1984, Regulation 18A (1): No person shall manufacture, sell, supply, import, possesses any cosmetics unless the cosmetic is a notified cosmetic. It is an offence for anyone to conduct such activities without prior notification to the DPS.
4. Post Market Surveillance Programme
Post Market Surveillance Activities, Product Sampling Requirements
4. Post Market Surveillance Programme
5. Regulatory Action
Rejection of Notification Submission, Cancellation of Notification Note & Punitive Action/Penalty
Step I : Preparation
Product classification, Token Configuration, Payment Mode, Patent and Data Exclusivity status and Ensure key documents availability.
Pre-submission of Application (Preparation)
Step 2 : Submission
Key-in, upload documents and submit your application (Part I, Part II, Part III & Part IV)
Product Validation, Part I, Part II, Part III & Part IV
Step 3 : Regulatory Outcome
Evaluation of Application & Drug Control Authority (DCA) decision.
Evaluation of Application & Drug Control Authority (DCA) decision.
Step 4 : Post-registration Process
Maintenance of Registration, Withdrawal of Product Registration, Amendment to the particulars of the product, Post marketing activities
Maintenance of Registration, Withdrawal of Product Registration, Amendment to the particulars of the product, Post marketing activities
Step 4 : Post-registration Process
Please report ALL suspected Adverse Drug Reactions (ADRs) to the National Centre for Adverse Drug Reactions Monitoring, including those for vaccines and traditional products.
Do not hesitate to report if some details are not known.
The identities of Reporter, Patient and Institution will remain confidential.
Please use this form to report product complaints (e.g. quality, efficacy, labelling, packaging) NOT related to ADRs.
Registered Products Complaints (Related to Medicine) Form [PDF]
Search Pharmaceutical, Complimentary & Alternative Products that registered with National Pharmaceutical Regulatory Agency, NPRA. You may also search cosmetic products notified with NPRA
REAKSI DRUG SAFETY NEWS
This publication provides information and recommendations to healthcare professionals to enhance communication of drug safety updates, raise
awareness of adverse drug reactions reported, and stimulate additional adverse drug reaction reporting.
Consumer Medication Information Leaflets (RiMUP)
Consumer Medication Information
Leaflet (RiMUP) is a copy of patient
information leaflet for a medicine,
which outline the conditions under
which the medicine should be used
and information on its
known safety.
Consumer Reporting of Side Effects to Medicines or Vaccines
To report a suspected side effect
or adverse drug reaction (ADR) to
any medicine or vaccine (including
prescription, over-the-counter,
or traditional products, health supplements,
vaccines, etc.)
Adulterated Poducts ( Unregistered )
NPRA telah menerima laporan kesan sampingan berkaitan produk-produk yang tersenarai di bawah dan hasil ujian yang telah dijalankan mendapati bahawa produk-produk ini telah dicampurpalsu dengan bahan terlarang atau racun berjadual.
Cancellation of Registered Complementary & Alternative Product
Produk-produk ini didapati mengandungi bahan kimia, termasuk racun berjadual yang tidak dibenarkan dalam Produk Komplementari dan Alternatif. Penggunaan produk-produk ini yang dicampurpalsu dengan bahan kimia seperti yang telah dikesan boleh menyebabkan kesan advers serius.
Cancellation of Notified Cosmetic Products
Produk-produk ini telah didapati mengandungi bahan larangan, termasuk racun berjadual yang tidak dibenarkan dalam produk kosmetik. Penggunaan produk kosmetik yang dicampurpalsu dengan bahan kimia seperti yang telah dikesan boleh menyebabkan kesan advers serius.
Online Public Engagement
This page is available for public consultation and will present new proposals or amendments to the draft law (including laws, policies, regulations, etc.). The draft will appear on this page within 14 working days. The public is encouraged to provide comments and views on the NPRA during this period.